|
|
175 |
|
HbA1c (%) (Mean) |
|
|
|
|
Baseline |
8.6 |
8.5 |
8.4 |
|
Change from baseline (adjusted mean) b |
-1.5 |
-1.5 |
-0.5 |
|
Difference from placebo + metformin + rosiglitazone arm (adjusted mean) b |
-0.9** |
-0.9** |
|
|
95% Confidence Interval |
(-1.1, -0.8) |
(-1.1, -0.8) |
|
|
Patients (%) achieving A1c <7% |
54 |
57 |
28 |
|
Fasting Plasma Glucose (mg/dL) (Mean) |
|
|
|
|
Baseline |
185 |
181 |
179 |
|
Change from baseline (adjusted mean) b |
-44 |
-40 |
-8 |
|
Difference from placebo + metformin + rosiglitazone arm (adjusted mean) b |
-36** |
-32** |
|
|
95% Confidence Interval |
(-44,- 27) |
(-41, -23) |
|
|
Body Weight (kg) (Mean) |
|
|
|
|
Baseline |
94.9 |
95.3 |
98.5 |
|
Change from baseline (adjusted mean) b |
-2.0 |
-1.0 |
+0.6 |
|
Difference from placebo + metformin + rosiglitazone arm (adjusted mean) b |
-2.6** |
-1.6** |
|
|
95% Confidence Interval |
(-3.4, -1.8) |
(-2.4, -1.0) |
aIntent-to-treat population using last observation on study
bLeast squares mean adjusted for baseline value
**p-value <0.0001
16HOW SUPPLIED/STORAGE HANDLING16.1 How SuppliedVictoza is available in the following package sizes containing disposable, pre-filled, multi-dose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL).
2 x Victoza pen NDC 0169-4060-12
3 x Victoza pen NDC 0169-4060-13
Each Victoza pen is for use by a single patient. A Victoza pen should never be shared between patients, even if the needle is changed.
16.2 Recommended StoragePrior to first use, Victoza should be stored in a refrigerator between 36°F to 46°F (2°C to 8°C) (Table 9). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Victoza and do not use Victoza if it has been frozen.
After initial use of the Victoza pen, the pen can be stored for 30 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Keep the pen cap on when not in use. Victoza should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the Victoza pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.
Table 9 Recommended Storage Conditions for the Victoza Pen
|
Prior to first use |
After first use |
Refridgerated
36°F to |
